Is The First Anniversary Of FDA's Approval Of Addyi A Reason To Celebrate?

This week, Thursday to be exact, marked one year since the Food and Drug Administration approved the controversial drug Addyi, dubbed the "female Viagra" because both medications are supposed to improve users' sex lives.

I've been covering health long enough to have written about Viagra on the first anniversary of its March 1998 approval (scroll down here). I know Viagra, and I can tell you, as far as sales and celebrity, not to mention how it works, Addyi is no Viagra.

Back in March 1999,
Pfizer was well on its way to meeting a projected $1 billion in sales of Viagra worldwide, making it the most successful first year of any drug up to that time. Former presidential candidate Sen. Bob Dole, who'd been treated for prostate cancer, was a Viagra pitchman.

That $1 billion figure has been mentioned in connection with Addyi, but it refers to the selling price when
Valeant Pharmaceuticals acquired the drug from Sprout Pharmaceuticals just two days after it won FDA approval. And while Viagra had Bob Dole, Addyi has no pitchwoman. Sprout had pledged (scroll down to page 15 here) to the FDA that Addyi would not be advertised on television or radio for at least its first 18 months on the market, apparently out of concern that physicians wouldn't be able to keep up with the demand from women seeking the drug to boost their flagging libido.

Addyi, the brand name for flibanserin, won Food and Drug Administration approval a year ago as the first drug to treat low libido in women. But questions about its safety and effectiveness as well as its high cost have prevented women from clamoring for it the way men demanded Viagra as soon as it came on the market. (AP Photo/Allen G. Breed)

As far as I can tell, though, there are far more physicians ready to prescribe Addyi than there are women wanting to take it.

Addyi, the brand name for flibanserin, is the first drug approved to treat hypoactive sexual desire disorder (HSDD), the most commonly reported form of sexual dysfunction. It is approved only for premenopausal women. (You won't find HSDD listed in the most recent edition of the Diagnostic and Statistical Manual of Mental Disorders, psychiatry's bible. It has been combined with female sexual arousal disorder as "female sexual interest/arousal disorder.")

Unlike Viagra, which men take on an as-needed basis for erectile dysfunction, women with HSDD are supposed to take Addyi every day, whether they're planning to have sex or not. While Viagra and other drugs for erectile dysfunction increase blood flow to the penis, they don't boost men's libido. By contrast, Addyi, originally studied as an antidepressant, works on brain chemistry.

Women with HSDD not only lack desire, but they feel distressed about it. Still, critics wonder, is medication the answer? Or, as registered nurse Anne Katz, a sexuality counselor at CancerCare Manitoba in Winnipeg, wrote in the June/July issue of the journal Nursing for Women's Health, "Are the things being labeled as women's sexual desire problems really problems to be fixed with a drug?

The FDA had twice rejected flibanserin, in 2010 and 2013. To press for approval, Sprout had helped launch a campaign called "Even the Score," charging that the FDA was biased against women because it hadn't greenlighted any drugs to help their sex lives.

The issue divided women's and health groups. Some defended the FDA, arguing that problems with the safety and effectiveness of flibanserin, not gender bias, had kept it off the market. A review of clinical trials assessing flibanserin's safety and effectiveness for HSDD, published in April in JAMA Internal Medicine, concluded that the drug on average resulted in one-half additional "satisfying sexual event" each month while "statistically and clinically significantly increasing the risk of dizziness, somnolence, nausea and fatigue."

A paper published online in June by the Journal of Medical Ethics described the Even the Score campaign as "deceitful and unethical use of moral arguments and concepts."

"It greatly contributes to the perception of lowered desire in women as a pathological condition that can and should be treated," wrote the authors--bioethicist Weronika Chanska and psychologist Katarzyna Grunt-Mejer, both university professors in Poland. "Being narrowly focused on the debatable biological grounds of lowered desire prevents couples from dealing fairly with the multiple factors that contribute to their relational problems." (Chanska told me that flibanserin hasn't yet been registered in Europe, so its use there would be illegal.)

The FDA finally approved Addyi after an advisory panel of outside experts in June 2015 voted 18-6 in favor of the agency taking that step.

On the anniversary of Addyi's approval, the National Women's Health Network (NWHN), a consumer advocacy organization based in Washington, D.C., gave Addyi "D"s, "F"s, and "I"s for "incomplete" on a report card assessing its first-year performance.

One "D" was for practicality. The low grade was due mainly to the fact that women who take Addyi aren't supposed to drink alcohol, because a safety study requested by the FDA found that the combination increased the risk of dizziness and fainting. Interestingly, 23 of the 25 participants in that study were men, for whom the drug is not approved (see the third page of the prescribing information for Addyi).

"The alcohol challenge study required participants to drink the alcoholic equivalent of a half to full bottle of wine within 10 minutes on a nearly empty stomach before taking Addyi," a Valeant spokeswoman explained in an emailed response to my questions. "More men than women agreed to enroll in this kind of study. Valeant is conducting additional alcohol studies in women."

However, one of of the "I" grades on the Addyi report card was for "promised studies." According to the NWHN, all of the post-market studies the FDA had required as a condition of approval are listed as "pending" on the agency's website, which means they haven't enrolled any subjects.

The Valeant spokeswoman, on the other and, said the company "is in the process of complying with all of our post-marketing commitments to the FDA on Addyi as scheduled."

The NWHN gave Addyi an "F" for product demand. "Addyi's market has been underwhelming, perhaps due to its high risks and low benefit," according to the report card. Cost, which is about $800 for a month's supply, could also be an issue.

IMS Health, a pharmaceutical information company, provided me with U.S. sales and prescription data for Viagra's and Addyi's first four months. Viagra sales totaled $323,491,461 in its first four months, compared to only $9,313,642 for Addyi. And Viagra racked up 3,794,028 prescriptions in its first four months compared to Addyi's 3,216.

While the Valeant spokeswoman would not disclose the latest sales and prescription data, she did say that "Addyi script volume has steadily increased since launch, and we are seeing the highest rates of paid claims since launch. Our most recent data suggest that a number of patients have refilled their prescriptions, some of them up to six times."

Physicians who want to prescribe Addyi and pharmacies that want to dispense it must be certified by the drug's Risk Evaluation and Mitigation Strategy, or REMS program, which the FDA required as a condition of approval because of the risk of dizziness and fainting. The Valeant spokeswoman told me that more than 35,000 doctors and more than 17,000 pharmacies have been certified. You'd have to ask your doctor to find out whether he or she is certified, but you can search by zip code on the Addyi REMS website for certified pharmacies.

I’ve been a journalist ever since I edited my elementary school newspaper in Wheeling, W.Va. My father was an ob-gyn, which helps explain why I gravitated toward covering health and medicine, with a special interest in women’s health. As a freelance writer, I’ve written for ...